Pramipexole for Restless Leg Syndrome in Peritoneal Dialysis Patients

Phase 4

Terminated

• Conditions: Restless Legs Syndrome
• Interventions: Other: placebo; Drug: Pramipexole

• Registration Number: NCT03817554
• Lead Sponsor: Dong Jie

Brief Summary

A randomized, double-blind controlled Study from a single center to evaluate the effect and safety of pramipexole on peritoneal dialysis patients with restless legs syndrome

Detailed Description

Peritoneal dialysis patients diagnosed with restless legs syndrome will be divided into experiment group and control group, and will be prescribed with pramipexole and placebo respectively.After 12 weeks, we will compare IRLSSG（International RLS Study Group Rating Scale）、MOS（Medical Outcomes Study ）Sleeping Scale、Self-Rating Anxiety Scale and Self-Rating Depression Scale before and after the prescription.

Study Timeline

• Study First Submitted: 2019-01-11
• Study First Submitted QC: 2019-01-23
• Study First Posted: 2019-01-25
• Study Start: 2019-07-01
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-28
• Last Update Posted: 2021-12-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. PD patients (aged ≥18 years) are dialyzed with lactate-buffered glucose dialysate, using a twinbag connection system (Baxter Healthcare, Guangzhou, China).
2. For entry , all patients are required to meet all diagnositic criteria of the International RLS Study Group (IRLSSG), to have a baseline total score >15 on the Study Group's International RLS Rating Scale (IRLS), and to have experienced RLS symptoms at least 2-3 days per week throughout the perior 3 months.
3. Each patient should write informed consent.
4. All patients are required to be interviewed to the frequency required by the research process.

Exclusion Criteria

1. Patients with severe gastrointestinal illness can not tolerate oral drugs.
2. Patients who work on a shift schedule are not allowed to participate.
3. Women with childbearing potential are excluded for pregnancy, inadequate contraception, or current breastfeeding of a child.
4. Patients are also excluded for current use (within 14 days before baseline) of medications that might affect RLS symptoms, e.g., levodopa, dopamine agonists or antagonists, hypnotics, lithium formulations, or antidepressants.
5. Patients with serum ferritin ≤200 ng/ml, or Hb <110g/L, or Kt/V <1.7 are excluded.
6. Patients with severe and unstable inflammation disease (active systemic infection, acute cardiovascular disease, active liver disease, active connective tissue disorder, ,and cancer within 1 year of radiotherapy and chemotherapy, )

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	placebo	Peritoneal dialysis patients diagnosed with restless legs syndrome will receive placebo.
Treatment group	placebo	Peritoneal dialysis patients diagnosed with restless legs syndrome will receive pramipexole.
Treatment group	Pramipexole	Peritoneal dialysis patients diagnosed with restless legs syndrome will receive pramipexole.

Primary Outcome Measures

Name	Time	Method
Absolute change in IRLSSG Score	12 weeks	Absolute change in IRLS sum score will be defined as a change in IRLSSG from baseline to the end of treatment phase. The scale range from 0 to 40. The higher values represent a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Effect on Sleep assessment Questionnaire	12 weeks	The absolute change of Sleep assessment Questionnaire between baseline and the twelfth week.The scale range from 0 to 60. The higher values represent a worse outcome.
Effect on Quality of life (QoL) questionare	12 weeks	The absolute change of QoL between baseline and the twelfth week. The scale range from 20 to 60. The higher values represent a worse outcome.The scale range from 36 to 162. The higher values represent a worse outcome.
Effect on self rating anxiety scale	12 weeks	The absolute change of self rating anxiety between baseline and the twelfth week. The scale range from 35 to 85. The higher values represent a worse outcome.
Effect on depression self rating scale	12 weeks	The absolute change of depression self rating between baseline and the twelfth week. The absolute change of self rating anxiety between baseline and the twelfth week. The scale range from 20 to 60. The higher values represent a worse outcome.
Effects on Blood pressure	12 weeks	The absolute change of 24-hour ambulatory blood pressure monitoring between baseline and the twelfth week. Both systolic and diastolic pressures will be assessed during the study period.

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, China